Brenda Hugh

Highly Effective Manufacturing/Quality Manager, Specializing in Technology Transfer, Lean Manufacturing and Quality

Systems  

Brenda Hugh– Presentation

Topics• A Manufacturing Management Centric Career

• Career Highlights

• A Career Focused on Product Quality and Customer Satisfaction

• Some Common Interview Questions

• Example Manufacturing Manager 90-day Plan

• Qualifications Summary

Charles Stark Draper Laboratories 1988-2001Design and development of novel, ultra-reliable, miniature diagnostic, therapeutic, and chemical-biological sensors.• Fabrication leader for micro-mechanical chemical sensor• Responsible for providing leadership, guidance, and direction regarding

product and process development• Lead effort for compliance with company's ISO Quality Management

System • Developed and implemented highly manufacturable silicon-on-insulator

fabrication process for production of chemical sensing • Demonstrated breakthrough multi-element array technology (8-element

and 64-element) based on existing dual-element array process• Created and implemented new, highly effective system for establishing

and maintaining safe operations in a fast-growing, state-of-the-art development laboratory

Experience Highlights• Career focused on product management and quality systems• 20+ years prospecting, identifying needs, providing value• Results and Science driven• Team player with experience on multidisciplinary teams• Confident and ethical• Self-motivated and disciplined• Advanced knowledge of quality system management (i.e. FDA

cGMP, ISO quality systems)

Brenda Hugh– A Manufacturing Management Centric Career

SRU Biosystems 2001-2012Label-free biosensor technology that enables detection of a variety of biomolecular interactions including Biochemical and Cell-based applications. • Manufacturing manager of biosensor product from

inception to current product line• Recognized leader for critical projects and

strategies for ensuring product quality. Designed and implemented in-coming, in-process and final quality control procedures

• Ensured all operations and documentation conform to cGMP standards and all SOPs and batch records are maintained to reflect current manufacturing methods and are in conformance with FDA, ISO 9001 and 13485 compliance

• Leader of technology-transfer for biological and chemical surface coating methods to manufacturing operations

• Design and executed small-scale experiments (DOE) and data analysis to support CAPA investigations, change control and continuous improvement projects to improve process robustness/capacity/productivity

• Responsible and accountable for deliverables and customer satisfaction, that they are on time and within budget

A Career Focused on Product and Customer Satisfaction

Proactive Leader of Premium Products

• Ability to understand customer needs and product performance

• Identified training needs, making certain that all personnel are trained to

adequately perform their assigned responsibilities

• Defined physical requirements of device and identified performance and

integrity criteria

• 100% testing of each phase of batch production

• Ensured all operations and documentation conform to cGMP/FDA/ISO

9001 standards and all SOPs and batch records are maintained to

reflect current manufacturing methods and are in conformance with

standards

• Drive yield and process improvements based on collected and

analyzed data

A wide scope of laboratory and life science knowledge & experience, working with customers to identify needs, provide solutions, and deliver quality products

Responses to Some Common Interview Questions

Some Common Interview Questions

What is your leadership style?• Key personal objective is to earn the trust, confidence and respect of

the employees, organization, and our customers

• Demonstrate a genuine appreciation and support for employees. Focus on the positives while understanding and communicating negatives in a positive way. Recognize and celebrate success, learn from failures

• Ensure that employees feel valued and respected, and understand how their efforts are contributing to the success of the organization

• Empower employees, achieve organization excellence through the collaborative skills and experience of the entire team

• Regular meetings are held to discuss solutions to problems not focusing on problems at hand

• Lead by example, with respect, integrity and honesty, deliver to commitments, champion data-driven decision making / problem solving

All the above, will lead to motivation of team members and success for the entire organization

Some Common Interview Questions

What are some of your basic beliefs?• Communication is the key to success

• Employees want to be appreciated. A simple “Thank You” or note to a colleague can go a long way.

• Training of processes early will lead to a smooth transition later

• Process improvement needs to be constant and ongoing. New processes for better ways of doing things should be encouraged and rewarded. Affect lasting change through a series of “small wins”, recognizing and communicating achievements, with a vision for future improvements and successes.

• Customer loyalty is achieved by earning their trust, confidence and respect through honest business / personal relationships and by consistent, timely and responsive delivery of exceptional quality products, services and support

Some Common Interview Questions

How would others describe you?• Trusted decision maker• Proactive• Engenders a culture of "get it done and get it done well"• Very committed to the success of the team and organization• Orderly, precise, disciplined, and deliberate• Methodical problem solver• Flexible, adaptable• High integrity and ethics• Strong business acumen • Grounded, excellent team player, always willing to help others• Very intuitive (anticipates others’ needs)• Perseveres; Always follows up when she says she will• “Leads by example”• “Very well respected by other colleagues and managers”• “An asset to any organization that she is a part of”

Some Common Interview Questions

What do people like most about you?

People find me likeable, down to earth, always willing to help, able to sense someone’s need and provide proactive help / information, the quality and thoroughness of my work / contributions, my attention to detail, helping others learn / understand something new, educating them in the course of their being helped; people find me easy-going yet determined and motivated What are your weaknesses?

An impatience for mediocrity, ineffectiveness and complacency (accepting the status quo)

Some Common Interview Questions

What achievements are you most proud of?• SRU Biosystems:

o Contributing to the efforts of product from start-up phase to a fully functional and

successful manufacturing facilityo Providing strong leadership of logistics, supply chain, manufacturing functions,

materials, and planningo Leading lean manufacturing and continuous product improvement initiatives aimed at

reducing cycle times, eliminating redundancies, and increasing throughput, resulting in

a 40% increase in yield and 35% reduction in cycle time o Leader of technology-transfer for optimized biological surface coatings for

immobilization of proteins, peptides, small molecules and nucleic acids, to

manufacturing operations• C.S. Draper Lab:

o Developed and demonstrated breakthrough multi-element array technology (8-element

and 64-element) based on existing dual-element array processo Developed and implemented highly manufacturable silicon-on-insulator fabrication

process for production of chemical sensing arrayso Created and implemented new, highly effective system for establishing and

maintaining safe operations in a fast-growing, state-of-the-art MEMS laboratoryo Recipient of Draper Recognition Award 1994-2000

Example Manufacturing Manager90-day Plan

Example Manufacturing Manager 90-day Plan

• Begin to earn the trust, confidence & respect of the team, while learning and assimilating into the company culture and organization

• Meet and greet members of the organization, have one-on-ones with team members & other key stakeholders

• Gain a clear perspective of the issues, challenges, opportunities, measures of success & areas for improvement

• Begin to build a strong, collaborative partnership with the organization & customers

• Understand the top 3 challenges of the organization and discuss options to meet those challenges

Observe, Listen & Learn• Develop an understanding of the

territory gaps & needs, including opportunities / needs for continued skills development

• Assess current approach and identify opportunities for changes in strategy

• Gain a fact-based understanding of the products and customers’ needs

• Prospect and develop new customers and material/equipment providers ; follow up on key opportunities

• Utilize methodical, data-driven techniques to identify new opportunities, where appropriate

Understand & Plan

• Deliver a clear communication of the manufacturing vision/goals and commitment

• Every action & decision must be focused on achieving our business objectives and improving our competitiveness

• Team focus on solutions to problems

• Motivate & empower the manufacturing team

• Recognize and celebrate success• Assess progress and update

plans accordingly

Implement & Monitor

Brenda Hugh3/9/2012

Qualifications SummaryTechnology . Relationships . Product success.

Qualifications Summary

• 20+ years in R&D and life

science industry

• Ability to learn new

products/technologies in

complex life science markets

• Understand technology and

link to customer needs

• Development of processes &

procedures

• Technology transfers

• Strategic vision / planning

• Proactive leadership

• Communication skills

• Cohesive team building

• Change agent, driving process

improvement and operational

excellence

• Deployment of common

processes, best practices,

knowledge sharing tools

• Collaborative team

management

• Product Quality Management

• Resource management,

human & capital assets

• Dept. planning, budgets,

metrics and objectives

• Customer facing roles,

meeting customer needs &

expectations

• Networking through

colleagues, industry leaders to

identify new processing

technologies

Technology Leadership Management

20+ years experience leading manufacturing & engineering teams, through a proactive and data-driven pursuit of excellence

Brenda Hugh

Thank you!